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510(k) Data Aggregation
(184 days)
UUHC REPROCESSED COMPRESSION SLEEVE DEVICES
UUHC's reprocessing methods do not change the intended use of the compression sfeeve devices (CSDs) from the intended use of, Kendall's K890938 model 5325 and K94664 model 6325 predicate devices. Both UUHC's reprocessed device and Kendall's predicate CSDs are intended to be placed on the intact skin of the patient's limb and to be periodically inflated for preventing pooling of blood in the patient's limb.
The description of UUHC's Reprocessed Compression Sleeves is substantially equivalent to the above described Kendall CSD. The primary descriptive difference between the two products is that UUHC's Reprocessed Compression Sleeves have been reprocessed as many as eleven (11) times and are labeled pasteurized and Kendall product is a nonsterile product that has not been reprocessed. The studies summarized in section 9,0 Safety and Efficacy and the comparison tables in section 5 demonstrate that UUHC's Reprocessed Compression Sleeves are substantially equivalent in physical, performance and safety characteristics to Kendall's CSDs.
Kendall's compression sleeve device (CSD) is an SUD and it is a component of Kendall's CSD System. The compression sleeve is an inflatable device generally made of PVC or Polyolefin attached to a pneumatic compression device called a controller that is capable of performing multiple low pressure inflation cycles. It is offered in four different sizes that are configured to fit on the patient's thigh or calf. The sleeves are constructed with a series of cells running the length of the patient's thigh or calf that are sequentially inflated to impart intermittent compression to the respective section of the limb. This "milking" action forces the blood flow in the direction of the heart and prevents back flow of blood. The sleeves are wrapped around the patient's limb and secured with valcor tabs.
The provided 510(k) summary for UUHC's Reprocessed Compression Sleeve Devices describes a submission for substantial equivalence to legally marketed predicate devices (Kendall K94664 and K890938 Compression Sleeve Predicate Devices). This type of submission focuses on demonstrating that the reprocessed device is as safe and effective as the predicate, rather than establishing de novo performance criteria against a disease state or clinical outcome.
Therefore, the "acceptance criteria" here are essentially showing that the reprocessed device does not perform worse than the predicate device across several key attributes. The "study" refers to the testing performed to demonstrate this equivalence.
Here's an analysis of the provided information, structured according to your request:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Demonstrated Equivalence to Predicate) | Reported Device Performance |
|---|---|
| Functional Equivalence: No functional characteristic changes that would pose substantial equivalency differences from the predicate devices after reprocessing multiple times. | Functional Testing: "The results of this test indicated that the CSDs can be reprocessed several times through the reprocessing steps with no functional characteristic changes that would pose any substantial equivalency differences from the predicate devices." |
| Intermediate Disinfection Capability: The pasteurization procedure is fully capable of and qualified for intermediate disinfection of the CSDs. | Intermediate Disinfection: "Based on test results the pasteurization procedure used for reprocessing CSDs is deemed fully capable of and qualified for intermediate disinfection of the CSDs." |
| Seal Strength: Seal strength, even if reduced after reprocessing, must not affect the function of the product in a simulated functional use test. | Seal Strength: "The seal strength of the samples reprocessed were reduced slightly due to reprocessing. The reduction of strength did not affect the function of the product in a simulated functional use test." |
| Biocompatibility/Toxicological Characteristics: Reprocessed CSDs can be used on patients without posing any new biocompatibility or toxicological hazard compared to the predicate device. | Biocompatibility/Toxicological Characteristics: "Based on test results, we conclude that the CSDs can be reprocessed and may then be used on the patient without posing any new biocompatibility or toxicological hazard to the patient." |
| Cleaning Efficacy: The cleaning process must effectively remove contaminants, ensuring no new safety or efficacy issues over the predicate device. | Cleaning Efficacy: "Based on test results, we conclude that the cleaning efficacy of the washer was capable or meeting the required cleaning efficacy end-point and that the cleaned reprocessed CSDs pose no new safety or efficacy issues to the patient over the predicate device." |
| Overall Safety and Efficacy: The reprocessed device is substantially equivalent in physical, performance, and safety characteristics to the predicate. | Substantial Equivalency: "The performance data and the safety data indicated that UUHC's Reprocessed CSDs were technically substantially equivalent. The reprocessed device was tested for biocompatibility and performance and they were substantially equivalent in all required categories to the predicate device." |
| Intended Use: The reprocessing methods do not change the intended use of the CSDs from that of the predicate devices. | Intended Use: "UUHC's reprocessing methods do not change the intended use of the CSDs from the intended use of, Kendall's K890938 model 5325 and K94664 model 6325 predicate devices." |
2. Sample size used for the test set and the data provenance
The document states that the devices can be reprocessed "as many as eleven (11) times" and that "the CSDs can be reprocessed several times". It also mentions "the seal strength of the samples reprocessed." However, specific sample sizes for each test (functional, disinfection, seal strength, biocompatibility, cleaning efficacy) are not provided in this summary. The provenance of the data is from UUHC's internal testing as part of their 510(k) submission. This is a prospective set of tests conducted specifically for this submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This submission is not clinical in nature in the sense of diagnosing a disease, but rather demonstrating the safety and effectiveness of a reprocessed medical device through bench testing. Therefore, there is no concept of "ground truth" derived from expert consensus like in an imaging study. The "ground truth" for each test is the objective measurement against established standards or the performance of the predicate device. The experts involved would be the engineers, microbiologists, and other technical specialists who conducted the tests and interpreted the results according to validated protocols. Their qualifications are not specified in the summary but would be relevant to the specific testing performed (e.g., a microbiologist for disinfection testing, material scientist for seal strength).
4. Adjudication method for the test set
Not applicable. This is not a study requiring adjudication of clinical findings or diagnoses.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is a 510(k) submission for a reprocessed physical medical device (compression sleeve), not an AI algorithm or a diagnostic imaging device requiring human reader interpretation. No MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI algorithm.
7. The type of ground truth used
The "ground truth" for the various tests was based on:
- Objective measurements and engineering specifications: For functional performance, seal strength, and cleaning efficacy, tests would have compared physical properties and cleanliness against predefined acceptable ranges or against the performance of new predicate devices.
- Microbiological standards: For intermediate disinfection, the "ground truth" would be the demonstrated reduction in microbial load to meet specific disinfection levels.
- Biocompatibility standards: For biocompatibility, the "ground truth" would be passing assays and tests against established ISO standards (e.g., ISO 10993).
- Intended Use of Predicate Devices: For intended use, the "ground truth" is the established indications for use of the original, legally marketed predicate devices.
Essentially, the ground truth is the performance of the predicate device and relevant industry/regulatory standards for medical device safety and effectiveness.
8. The sample size for the training set
Not applicable. This is not a machine learning model; therefore, there is no "training set."
9. How the ground truth for the training set was established
Not applicable. There is no training set.
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